Bionet for bilateral cochlear implant systems

ABSTRACT

A system for allowing bilateral cochlear implant systems to be networked together. An adapter module that forms part of the system allows two standalone BTE units to be synchronized both temporally and tonotopically in order to maximize a patients listening experience. The system further allows a peer-to-peer network and protocol that includes two BTE units during normal operation, or two BTE units plus a host controller (PC, PDA, etc. . . ) during fitting. The bilateral cochlear network includes four main components: (a) a communications interposer adapted to be inserted between the BTE battery and the BTE housing or modified BTE devices; (b) a communication channel over which communication takes place between the connected devices, including the protocol governing access to such channel; (c) the synchronization mechanisms used to achieve synchronization between the connected devices; and (d) a bilateral fitting paradigm.

The present application is a Continuation of U.S. patent applicationSer. No. 10/218,615, filed Aug. 13, 2002, which claims the benefit ofU.S. Provisional Patent Application Ser. No. 60/313,694, filed Aug. 20,2001, which application, including its Appendix A, is incorporatedherein by reference in its entirety.

BACKGROUND OF THE INVENTION

The teachings of the present disclosure relate to bionic ear implants,and more particularly to an ear level high resolution bilateralprogramming system for use with a bionic ear implant.

A new generation of cochlear implants, commonly referred to as a “bionicear” implant, has recently been introduced to the cochlear implantcommunity. A representative bionic ear implant is the CII Bionic Ear™cochlear implant system introduced by Advanced Bionics Corporation, ofSylmar Calif. A bionic ear implant is capable of delivering electricalstimulation to a patient at rates and resolutions which surpass that ofconventional cochlear implants.

Early research indicates that cochlear implant patients will benefitfrom additional synchronized and processed speech information conveyedto the brain via both the right and left auditory nerve pathways.Several configurations are available to implement such a system,including, e.g.: (a) bilateral implants controlled by a single masterspeech processor; (b) bilateral implants driven by independent externalspeech processors; and (c) bilateral implants driven by synchronizedexternal speech processors. The teachings of the present disclosurerelate primarily to configurations (b) & (c).

Of significance to configuration (c) is its ability to interface withpatients who use presently available technology platforms; specificallyear level early-generation speech processors. (The early-generationspeech processors are referred to herein as “CI” processors, whereas themore recent bionic ear processors are referred to as the “CII”processors.) With or without a hardware change to a standalonebehind-the-ear (BTE) processor, there is a need for an adapter modulewhereby two standalone BTE units may be synchronized both temporally andtonotopically to maximize the CI patients listening experience. There isalso a need for a peer-to-peer network and protocol consisting of twoBTE units during normal operation, or two BTE units plus a hostcontroller (PC, PDA, etc . . . ) during a fitting session.

SUMMARY OF THE INVENTION

The present disclosure addresses the above and other needs by providingan adapter module that allows two standalone BTE units to besynchronized both temporally and tonotopically in order to maximize theCl patients listening experience. Further, the present disclosureprovides a peer-to-peer network and protocol that consists of two BTEunits during normal operation, or two BTE units plus a host controller(PC, PDA, etc . . . ) during fitting.

The system provided by the present disclosure includes (a) acommunications interposer adapted to be inserted between the BTE batteryand the BTE housing or modified BTE devices; (b) a communication channelover which communication takes place between the connected devices,including the protocol governing access to such channel; (c) thesynchronization mechanisms used to achieve synchronization between theconnected devices; and (d) a bilateral fitting paradigm. Each of thesefour components of present disclosure are summarized below.

(a) Communications Interposer. The communications interposer is aplug-in module designed for use with the Clarion® BTE (a CI device). Itinterfaces mechanically to the existing clinicians programming interface(CPI) contacts found on the underside of a standard platinum series BTE.The interposer module contains the interface electronics to the physicallayer (any necessary antennae or connectors) and a replicated batteryport on its underside to allow insertion as usual of a BTE battery.

(b) Communication Channel. The communication channel may be a wired orwireless link configured to use proprietary technology (e.g. theimplantable speech processor's 10.7 MHz ITEL channel) or industrystandard channels (e.g. the newly allocated 400 MHz medical band,Bluetooth, 802.11, etc . . . ). One preferred embodiment uses wiredinterconnections of multiple speech processors and a fitting station viathe buffered serial ports that are standard on Texas Instruments DSPproducts. In the case of wired links, interference is not a problem andthe fundamentals of an enhanced packet protocol are utilized. For awireless embodiment, bandwidth and interference issues bound theultimate capability and robustness of the system. Any time there is aneed to maintain communications in real time between two operatingprocessors, there are many tradeoffs to consider, leaving certainimplementations fundamentally superior to others. Conversely, developingnew applications to run over an industry standard link utilizingindustry standard protocols (e.g. Bluetooth) may simplify thedevelopment of new applications.

(c) Synchronization. The raw bandwidth and necessary protocol overheadof a chosen physical medium dictates the nature of information that canbe passed over the network in real time. This, in turn, limits thedegree to which parallel speech processors can synchronize theiractivities and/or share information. In a preferred embodiment, amaximally efficient data link layer is used that allows for arbitrarydata exchange and device synchronization. Disadvantageously, varyingdegrees of reduced functionality are mandated as the system'scommunication bandwidth is reduced and/or as protocol overheadsincrease. To minimize such reduced functionality, several steps aretaken. First, a fitting mechanism is used that tonotopically rankselectrode contact position in the contra-lateral cochlea, followed byassignment of audio frequency bands to those optimal contacts. Second,an operational mode is used that offers noise cancellation anddirectional hearing by making use of phase information available fromthe contra-lateral microphones. Third, an operational mode is describedfor listening in stereo.

(d) Bilateral fitting Paradigm. A fitting procedure, based ontrans-cochlear pitch discrimination, is used so as to reduce channelinteraction and optimally interleave channel information acrossavailable electrode contacts.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of the present disclosure will be moreapparent from the following more particular description thereof,presented in conjunction with the following drawings, wherein:

FIG. 1 is shows a simple binaural interposer;

FIG. 2 shows a binaural programming cable suitable for use with aClinician Programming Interface (CPI) device;

FIG. 3 depicts a BioNet BTE interposer;

FIG. 4 shows a BioNet Wireless BTE communications controller;

FIG. 5 depicts a first configuration for a binaural fitting cable;

FIG. 6 illustrates a second configuration for a binaural fitting cable;

FIG. 7 illustrates a third configuration for a binaural fitting cable;

FIG. 8 shows a fourth configuration of a fitting cable;

FIG. 9 shows a binaural standalone approach;

FIG. 10 depicts a wired binaural fitting mode;

FIG. 11 shows a BioNet Wireless fitting system.

FIG. 12 illustrates a cascaded master/slave bootload operation;

FIG. 13 shows stimulation synchronization;

FIG. 14 depicts audio synchronization;

FIG. 15 illustrates a fitting system framework; and

FIG. 16 conceptually illustrates a bilateral fitting paradigm.

Additional details regarding the CII Bionic Ear™ implant, and theBioNet, or communications network, that may be established between twobionic ears, or other biotechnology-based devices, in accordance withthe present disclosure, including case studies and performance data, maybe found in Appendix A of the earlier-referenced provisional patentapplication, Ser. No. 60/313,694; filed Aug. 20, 2001, previouslyincorporated herein by reference.

Corresponding reference characters indicate corresponding componentsthroughout the several views of the drawings.

DETAILED DESCRIPTION OF THE INVENTION

The following description is of the best mode presently contemplated forcarrying out the invention. This description is not to be taken in alimiting sense, but is made merely for the purpose of describing thegeneral principles of the invention.

Turning first to FIG. 1, there is shown a simple binaural interposer 23that may be used as part of the present disclosure. The BTE speechprocessor 22 is normally connected to a removable battery 24. To insertthe interposer 23, the battery 24 is removed from the BTE processor 22,and the interposer 23 is inserted between the BTE processor 22 and thebattery 24. The battery 24 may then be connected to the underneath sideof the interposer 23.

The interposer 23 has a BTE interface port 25 on the side thereof thatis placed against the BTE processor. Such interface port allowselectrical connections to be made with the circuits within the BTEprocessor. A binaural communications port 26 is on one side of theinterposer 23. This port, used for a wired implementation, allows acable to be attached thereto that connects with another BTE processor,or to a programming device, such as a host fitting station. Powerconnections or terminals are also provided on the interposer 23 so as toallow the power terminals on the battery 24 to make electricalconnection with the power input terminals on the BTE speech processor22. Thus, Power In terminals are located on a side 27 of the interposer23 that is placed adjacent the battery terminals, and Power OUTterminals are located on a side 28 of the interposer that is placedadjacent the BTE processor, thereby allowing power to pass through theinterposer from the battery to the BTE processor.

Turning next to FIG. 2, an enhanced binaural interposer 30 is depictedthat includes a binaural CPI programming cable 32 exiting from a bottomside thereof. The acronym CPI stands for “clinician programminginterface”, and refers to a special interface unit that allows theclinician's programmer (usually a laptop computer) to interface with theBTE processor that is being programmed. The CPI programming cable 32 isan extension to an existing BTE/CPI Programming Cable. On one end it isterminated with a standard DB15 connector for connection to a standardCPI-2. On the other end, it is terminated with the enhanced binauralinterposer 30. The enhanced interposer 30 performs CPI signal levelshifting, power distribution and BSP (body speech processor)interconnection between a Master BTE (to which the interposer isattached), a slave BTE (to which the interposer is tethered) and the CPI(host PC). This is used for wired fitting of the system. Multiplevariations of the enhanced interposer 30 are possible, as described,e.g., in FIGS. 5, 6 and 7, below. The fitting system is embodied in a“Wired Binaural Fitting Mode”.

Next, with reference to FIG. 3, a BioNet BTE interposer 40 is shown. Theinterposer 40 houses a wireless transceiver (Bluetooth, ISM, MedicalBand, FIS ITEL, etc . . . ) for wireless communication betweenbinaurally co-joined BTE's and/or a host fitting station. The interposer40 includes the same or similar connectors, e.g., Power In, Power Out,BTE interface port 25, binaural cable port 26 (optional), and furtherincludes an optional CPI programming cable port 42. In a singular mode,the wireless link provided through the wireless transceiver can be usedto fit a remote BTE. A more powerful mode provided by the interposer 40is simultaneous fitting of synchronized BTE pairs.

A block diagram of the control subsystem necessary to implement a BioNetis shown in FIG. 4. That which is shown in FIG. 4 functionallyrepresents the circuitry contained within the interposer 40. As seen inFIG. 4, a control module 44 interfaces with the local BTE 22 and localbattery 24 through the BTE interface port 25 and power connections.Internal to the interposer 40, the control module 44—typically realizedfrom microprocessor circuitry—interfaces with both a wireless networkinterface module 43 and a wired network interface module 46. Thewireless network interface module 43 has an antenna coil 45 connectedthereto. Such antenna coil 45 is advantageously embedded within thehousing of the interposer 40 so that it is not obtrusively visible to auser of the BioNet, which BioNet is made possible by the interposer 40.The wireless network interface module 43 may connect to one or moreremote BTE's. The wired network interface module 46 may connect to aremote BTE through the binaural cable port 26, or to a host fittingsystem through the CPI programming cable port 42.

FIG. 5 illustrates a standalone wired interconnection of two BTE's, amaster BTE 22, and a slave BTE 22′, via simple binaural interposers 23and 23′, and a binaural interface cable 21. The wiring of the binauralinterface cable 21 is illustrated in FIG. 9.

FIGS. 6, 7 and 8 respectively show variations of a master BTE 22connected to a slave BTE 22′. In FIG. 6, an enhanced interposer 30connects the master BTE 22 to a CPI device 52, while a binauralinterface cable 21 connects the slave BTE 22′ to both the CPI 52 and themaster BTE 22 through a simple interposer 23′. In FIG. 7, a BioNet BTEinterposer 40 connects the master BTE 22 to a CPI device 52, while abinaural interface cable 21 connects the slave BTE 22′ to both the CPI52 and the master BTE 22 through a simple interposer 23′. In FIG. 8, twoenhanced interposers 30 and 30′ are used to respectively connect aprimary BTE 22 and a secondary BTE 22′ to respective CPI's 52 and 52′.Dual Port Fitting Software 54 interfaces with each of the respectiveCPI's 52 and 52′.

Turning next to FIG. 10, a wired binaural fitting mode is illustrated. Aslave BTE 22′ is connected through, e.g., a simple interposer 23′ and asynchronous binaural interface cable 21 to an enhanced interposer 30.The enhanced interposer 30 is connected to a master BTE 22. The binauralfitting cable 32 that exits from the enhanced interposer 30 (see FIG. 2)is connected to a CPI device 52. The CPI device 52, in turn, isconnected to a host programming system, e.g., a laptop computer (notshown) loaded with the appropriate fitting software.

Next, with reference to FIG. 11, a BioNet Wireless Fitting System isillustrated. FIG. 11 embodies the operational modes for fitting andoperating a wireless BTE fitting system. As seen in FIG. 11, the systemconsists of two BioNet BTE Interposers 40, each connected to arespective BTE 22, and a BioNet PC Card 56 plugged into the host fittingstation 58. As thus configured, a BioNet 60 is created that allowseither BTE to be coupled to the host fitting station 58, and thatfurther allows either BTE to be coupled to the other BTE.

FIG. 12 illustrates the preferred cascaded Master/Slave bootloadoperation relative to a CPI device, a Master BTE and a Slave BTE. Asseen from FIG. 12, in keeping with the architecture of present dayspeech processors, a cascaded bootload scenario is presented wherebycable interconnection as per “Fitting Cable Configuration #2”, FIG. 6,is employed. The “Command/Response” handshaking is defined in the seriallink protocol and is presently controlled from the PC side by PPMIF.DLL(or equivalent). First, the need to utilize multiple target addresses(destination field in the packet protocol) is required. Secondly,monitor functions running on the DSP require master & slave awarenesswith all incoming commands (from the host) delivered to the master forprocessing or forwarding (based on destination address) and allacknowledges to the PC delivered from the slave (directly or by way offorwarding from the master).

The key to the startup is a double blind bootload. That is, bootloadingis a blind process, the success of which cannot be determined until theoperation is complete and a PING is received from the remote kernel. Inone binaural configuration, this blind operation is cascaded. For theBTE processor to become operational, a bootload to the master isperformed (identical to the present day single speech processorenvironment). Upon completing the master bootload sequence, the slavebootload sequence is forwarded by the now operational master BTE to theslave BTE. Once both BTE's have been bootloaded, success can bedetermined by issuing a PING to the master BTE. The ping response isrouted through the slave BTE and returned to the host PC through theCPI. Receipt of this acknowledgment indicates success.

Once a bootload has been successfully made, application programs can beloaded as per an existing packet protocol with the caveat thatdestination addresses will determine which BTE processor processes eachcommand.

FIG. 13 illustrates how stimulation synchronization is obtained betweenthe Master BTE and the Slave BTE.

FIG. 14 shows the manner in which audio synchronization is obtainedbetween the Master BTE and the Slave BTE.

FIG. 15 depicts a fitting system platform. Such platform allowsoperation with the various binaural speech processor configurationsdescribed above. The platform includes a host fitting station 58,typically comprising a laptop computer loaded with the appropriatefitting software. Also included in the platform is a BioNet PC card 56,or equivalent, that is plugged into the fitting station 58, therebyallowing communications with two BTE's 22, one BTE being for the leftear and the other BTE being for the right ear. Each BTE is coupled to aheadpiece 21. The headpiece 21, in turn, is coupled to the bionic earimplant 18, which implant includes an electrode array 19. A multiplicityof electrode contacts, e.g., 16 electrode contacts, are spaced apartalong the length of the array 19, thereby allowing stimulation ofcochlea tissue to occur at various locations along the length of thearray.

Fundamental to the platform shown in FIG. 15 are means to performbilateral pitch ranking and channel allocation. This process of pitchranking is illustrated in FIG. 16, and is further explained in AppendixA of the above-referenced provisional patent application, Ser. No.60/313,694, filed Aug. 20, 2001, previously incorporated herein byreference.

While the invention herein disclosed has been described by means ofspecific embodiments and applications thereof, numerous modificationsand variations could be made thereto by those skilled in the art withoutdeparting from the scope of the invention set forth in the claims.

1. A bilateral cochlear implant system comprising: a local bionic earsystem having a local BTE unit associated therewith, and a remote bionicear system having a remote BTE unit associated therewith, each BTE unitcomprising a processor, a battery module, and a cochlear array; twointerposer modules, one adapted to be inserted between the processor andbattery module of the local BTE unit, and the other adapted to beinserted between the processor and battery module of the remote BTEunit, each interposer unit having means for making electrical andmechanical connection with the processor and battery module of therespective BTE unit; a communication means for allowing signalcommunications to take place between the local BTE unit and the remoteBTE unit; a network medium for synchronizing the signal communicationsthat occur over the communications means; and a bilateral fittingparadigm for cooperatively programming the local BTE unit and the remoteBTE unit.
 2. The bilateral cochlear implant system of claim 1 whereineach of the interposer modules comprises a binaural interposer modulehaving a binaural communications port into which an interface cable isadapted to be detachably connected for coupling to another interposermodule, thereby providing a direct wired network connection between thetwo BTE units.
 3. The bilateral cochlear implant system of claim 1wherein at least one of the interposer modules comprises an interposermodule, the interposer module having: a binaural communications portinto which an interface cable is adapted to be detachably connected forcoupling to another interposer module, thereby providing a direct wirednetwork connection between the two BTE units, and a binaural fittingcable adapted for connection to a host clinician programming interface(CPI) unit.
 4. The bilateral cochlea implant system of claim 1 whereinat least one of the interposer modules comprises a network BTEinterposer module having built-in wireless communication transceiver forallowing signal communications with another network BTE interposermodule.
 5. The bilateral cochlear implant system of claim 4 wherein thewireless communication transceiver further allows signal communicationswith a host clinician programming interface (CPI) unit.
 6. The bilateralcochlear implant system of claim 4 wherein the wireless communicationtransceiver is selected from the group comprising Bluetooth, ISM,Medical Band, FIS ITEL, and the like.
 7. The bilateral cochlear implantsystem of claim 1 wherein at least one of the interposer units comprisesa first terminal for making electrical and mechanical connection withthe respective BTE unit; a second terminal for making electrical andmechanical connection with the battery module adapted for use with therespective BTE unit; a control unit operatively coupled to the first andsecond terminals; a wireless network interface module coupled to thecontrol unit, wherein the wireless network interface module has anantenna through which wireless communications may take place; and awired network interface module coupled to the control unit, wherein thewired network interface module has a remote BTE connection port and afitting system port through which wired communications with the remoteBTE or a clinician programming interface (CPI) unit may optionally takeplace.
 8. The bilateral cochlear implant system of claim 1 wherein thechannel communication means includes means for performing a cascadedmaster/slave bootload operation.
 9. The bilateral cochlear implantsystem of claim 1 wherein the bilateral fitting paradigm includes afitting procedure, uses trans-cochlear pitch discrimination, whereinpitch discrimination reduces channel interaction and optimallyinterleaves channel information across available electrode contacts.